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RecruitingInterventional

Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy

NCT ID: NCT06473103Sponsor: University of RochesterLast updated: 2025-03-17

Summary

The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.

Detailed description

This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.

Arms & interventions

  • DeviceTwo photon fluorescence microscopy imaging

    Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.

Outcome measures

Primary

  • Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology

    The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated.

    Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery

Secondary

  • Overall agreement on margin status

    Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: No
Inclusion Criteria: * Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site * Able to read and understand consent form Exclusion Criteria: * None

Study locations (1)

Rochester Dermatologic Surgery

Victor, New York, 14654

Recruiting
Sherrif Ibrahim, MD-Ph.D. · Contact

References

  • Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.(PubMed)
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy | Cancerify